Required Skills & Experience

Technical Skills

• Expert‑level SAS programming skills.
• Strong, hands‑on experience with CDISC SDTM, ADaM and TLFs.
• Proven experience developing safety, PK, and PK/PD ADaM datasets.
• Experience supporting POPPK/popPD/Exposure Response(ER) dataset creation workflows.
• Solid understanding of early‑phase clinical trial designs, including:
• Phase I / First‑in‑Human
• Crossover studies
• Exposure–response analysis
• PK parameter pooling

Experience

• 8+ years of statistical programming experience in the pharmaceutical or CRO environment.
• Demonstrated experience as a Lead Programmer or technical lead.
• Prior experience working in an FSP engagement model preferred.
• Experience supporting regulatory submissions is required.

Soft Skills

• Strong communicati...